Own and Manage Regulatory Processes and Risk Take full responsibility for all regulatory processes within the team, ensuring timely execution and proactive risk management across the entire regulatory scope. Support Cross-Functional Projects and Process Optimization Provide comprehensive regulatory expertise to internal functions and project teams (e.g. manufacturing transfers).
POSITION Globally responsible for product regulatory compliance regarding food contact materials, cosmetic and pharmaceutical packaging for Flint Group manufactured and resale products Managing and developing the global regulatory team, mainly located in Europe and the US, and ensuring close alignment with the various stakeholders in the divisions Defining and executing the regulatory affairs strategy and implementing policies, guidelines and best practices Developing and maintaining accurate and up to date regulatory digital documentation and paperwork towards customers; ensuring timely and complete response to regulatory requests Driving projects to achieve and maintain international and/or national regulatory compliance for new and existing products Performing and/or organizing risk assessments for substances used/present in the products based on scientifically acceptable methods Liaising and negotiating when necessary with regulatory authorities Representing or coordinating representation of Flint Group in trade associations; communicating the necessary information to the regulatory and/or business teams Designing scenarios for possible future developments and implications Reporting to the Senior Director Product Stewardship & Regulatory Affairs.
Außerdem verantworten Sie das Monitoring und Reporting des Deployment-Fortschritts am Standort und nehmen regelmäßig an den Project Support Community Meetings teil. Ihr Profil: Must-haves Abgeschlossenes Studium im Bereich Life Sciences, Pharmazie, Biologie, Chemie oder Regulatory Affairs – oder vergleichbare Qualifikation mit Berufserfahrung; auch als Regulatory Affairs Specialist (m/w/d), Regulatory Operations Specialist (m/w/d) oder RIM Data Specialist (m/w/d) sind Sie willkommen.
Außerdem verantworten Sie das Monitoring und Reporting des Deployment-Fortschritts am Standort und nehmen regelmäßig an den Project Support Community Meetings teil. Ihr Profil: Must-haves Abgeschlossenes Studium im Bereich Life Sciences, Pharmazie, Biologie, Chemie oder Regulatory Affairs – oder vergleichbare Qualifikation mit Berufserfahrung; auch als Regulatory Affairs Specialist (m/w/d), Regulatory Operations Specialist (m/w/d) oder RIM Data Specialist (m/w/d) sind Sie willkommen.
As a Principal Biostatistician you will liaise with cross-functional teams, to drive the quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions.Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.
Act as a Senior Finance Business Partner for R&D, Quality/Regulatory, and Medical Affairs, providing financial insights and decision support to senior stakeholders Lead project controlling for R&D projects and clinical studies, including budgeting, forecasting, cost tracking, and performance analysis Ensure transparency of project costs, resource utilization, and key cost drivers to enable effective financial steering of development activities Drive the standardization and continuous improvement of controlling processes, KPIs, and reporting tools across the organization Serve as SAP Key User for CO and PS, supporting project structures, cost allocation logic, and reporting, as well as contributing to SAP ECC6 and S/4HANA implementation and optimization initiatives Degree in Business Administration, Finance, Controlling, or a related field Robust experience in controlling, preferably within the Life Sciences, MedTech, or Pharmaceutical industry Strong background in project controlling for R&D projects or clinical studies, including business case evaluation and financial performance management Advanced SAP expertise, particularly in SAP CO and PS, with experience using SAP BW / Analysis for Office and advanced Excel reporting Proven business partnering and stakeholder management skills, with the ability to challenge senior leaders in a constructive manner; fluent English and solid German skills required Challenging and varied tasks in a promising and innovative industry Flat hierarchies Individual development opportunities Ihr Kontakt Referenznummer 865253/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt
Act as a Senior Finance Business Partner for R&D, Quality/Regulatory, and Medical Affairs, providing financial insights and decision support to senior stakeholdersLead project controlling for R&D projects and clinical studies, including budgeting, forecasting, cost tracking, and performance analysisEnsure transparency of project costs, resource utilization, and key cost drivers to enable effective financial steering of development activitiesDrive the standardization and continuous improvement of controlling processes, KPIs, and reporting tools across the organizationServe as SAP Key User for CO and PS, supporting project structures, cost allocation logic, and reporting, as well as contributing to SAP ECC6 and S/4HANA implementation and optimization initiatives Degree in Business Administration, Finance, Controlling, or a related fieldRobust experience in controlling, preferably within the Life Sciences, MedTech, or Pharmaceutical industryStrong background in project controlling for R&D projects or clinical studies, including business case evaluation and financial performance managementAdvanced SAP expertise, particularly in SAP CO and PS, with experience using SAP BW / Analysis for Office and advanced Excel reportingProven business partnering and stakeholder management skills, with the ability to challenge senior leaders in a constructive manner; fluent English and solid German skills required Challenging and varied tasks in a promising and innovative industry Flat hierarchies Individual development opportunities Ihr Kontakt Referenznummer 865253/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt
If you have experience with consumer healthcare customer interaction it is a great advantage. You have a proven track record of running global projects showcasing your ability to lead in-directly and making a positive impact on business and collaborations. Strong communication skills are key to success and besides fluency in English (written and spoken) you have an in-ternational mindset and the ability to work in a matrix environment.
If you have experience with consumer healthcare customer interaction it is a great advantage. You have a proven track record of running global projects showcasing your ability to lead indirectly and making a positive impact on business and collaborations. Strong communication skills are key to success and besides fluency in English (written and spoken) you have an international mindset and the ability to work in a matrix environment.
Presenting project progress and critical issues to steering committees Your Profile: Completed degree in business administration, engineering, or a comparable field Required professional experience: 5 years, ideally in the area of supply chain or project management Alternatively, you have experience in regulatory affairs, quality assurance, or pharmacovigilance You already have some experience in coordinating cross functional teams and complex projects You are characterized by analytical thinking and a structured and results-oriented approach to work You communicate and negotiate confidently in German and English and have a good working knowledge of MS Office; knowledge of SAP is an advantage Your way of working is proactive, solution-oriented and communicative Unser Angebot: A growing company with a diverse and open-minded working environment with employees from around 40 different countries Flexible working models adapted to your needs (e.g. up to 100% remote working and up to two months from abroad within the EU possible), working time account with time off in lieu, 30 days' holiday Flexible benefits budget that you can use according to your individual preferences, such as a higher employer contribution to the company pension scheme, fitness & health offers or subsidies for travel or meal costs.
Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
Job Overview: As an Associate Director, Biostatistics, with regional/site presence, you will manage a team of Biostatistics staff and fulfil the role of site head or functional head within a site. You will provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.
Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
Executive Reporting and Stakeholder Communication Provide strategic updates, risk assessments, and clear go/no-go recommendations to the department and company leadership. Drive stakeholder alignment by translating project complexity into concise, action-oriented insights. Your Profile: Master's degree in Business Management, Business Administration or comparable At least 5 - 10 years of relevant professional experience in Project Planning and Risk Management in the pharmaceutical industry (must-have) Excellent analytical and problem-solving skills with a strategic, results-driven approach A persuasive and resilient professional with excellent communication and relationship-building skills You are confident in using standard MS Office programs and project management tools (MS Project, Planner etc.)